EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study (EXCITE)

July 29, 2014 updated by: University of California, San Francisco
The purpose of this study is to inform the integration of mobile and social media components into larger interventions aimed at increasing adherence and maintenance of physical activity. Nearly half of the US population do not meet physical activity recommendations of ≥150 minutes of moderate activity per week. The use of smartphones to "self track" data and upload that data to an online social network is becoming increasingly common and may be an effective way to motivate physical activity adherence and maintenance. We are proposing a two phase study to develop and evaluate a mobile health ("mHealth") intervention that includes the use of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to collect feasibility, acceptability and preliminary efficacy data. All participants will attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their coach and community in-person. All participants will also be asked to wear a FitBit accelerometer from one week before the beginning of the intervention through one week after the end of the intervention to collect total physical activity data. This data will be uploaded automatically to the study data base. Primary outcomes will be total physical activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the intervention group) and secondary outcomes will be changes in psychological factors that may mediate adherence to physical activity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Osher Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy underactive adults interested in using mobile and web based technologies to increase their physical activity
  • low risk of cardiovascular disease
  • comfortable reading and communicating in English
  • owns a smartphone and is does not regularly use a fitness tracking mobile app
  • has regular access to the internet and a wireless connection for data uploading.

Exclusion Criteria:

  • currently meeting/exceeding recommend 450 MET min per week
  • previous condition that would contraindicate regular moderate to vigorous physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
ChiRunning training Weekly training log Blinded accelerometer
Behavioral: ChiRunning training
Experimental: Technology support for behavior change
ChiRunning training unblinded accelerometer tracking structured exercise using mobile app participation in online social network participation in study website
Behavioral: ChiRunning training
Behavioral: unblinded accelerometer
Behavioral: participation in online social network
Behavioral: participation in study website
Behavioral: Technology support for behavior change

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment
Time Frame: End of 8 weeks of recruitment
Meeting 75% of recruitment goal of 40 participants
End of 8 weeks of recruitment
Feasibility of retention
Time Frame: End of 10 weeks of participation
Retaining 75% of enrolled participants.
End of 10 weeks of participation
Feasibility for participant adherence
Time Frame: Measured through out the 10 weeks of active participation
Whether participants complete at least 75% of the exercise that they committed to at the beginning of the study.
Measured through out the 10 weeks of active participation
Acceptability of study procedures
Time Frame: End of 10 weeks of active participation
Did participants find study procedures acceptable?
End of 10 weeks of active participation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total number of new exercise related injury
Time Frame: Measured through out the 10 weeks of active participation
Measure of pain or injury associated with structured exercise.
Measured through out the 10 weeks of active participation
Average weekly physical activity in steps
Time Frame: Measured through out the 10 weeks of active participation
Daily step measured using a digital accelerometer.
Measured through out the 10 weeks of active participation
Average weekly MET min of structured exercise
Time Frame: Measured through out the 10 weeks of active participation
Average weekly metabolic equivalent of task (MET) minutes are a measure of time and intensity of physical activity.
Measured through out the 10 weeks of active participation
Change in mindfulness
Time Frame: Baseline and end of 10 weeks of active participation
We will use the Five Factor Mindfulness Questionnaire (FFMQ) to assess changes in mindfulness. FFMQ is a 39-item questionnaire with five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience) and a summary score ranging from 39 to 195. Internal consistencies range from α=0.75-0.91.
Baseline and end of 10 weeks of active participation
Change in body awareness
Time Frame: Baseline and end of 10 weeks of active participation
We used the Multi-dimensional Assessment of Interoceptive Awareness (MAIA) to measure body awareness. MAIA is a 32-item questionnaire with eight separately scored scales. .We used 3 of the 8 scales most relevant for an exercise intervention to assess body awareness. The subscales we used were: 1) Self-Regulation: ability to regulate distress by attention to body sensations; 2) Body Listening: active listening to the body for insight; 3) Trusting: experience of one's body as safe and trustworthy. Scales range from 0-5 with higher numbers representing higher aspects of body awareness with internal consistencies of α=0.83; 0.82; 0.79 on the Self-Regulation, Body Listening, and Trusting subscales, respectively.
Baseline and end of 10 weeks of active participation
Change in exercise self efficacy
Time Frame: Baseline and end of 10 weeks of active participation
We will be using Multidimensional Self-Efficacy for Exercise Scale (MSES) to assess exercise related self efficacy. MSES is a 9-item instrument used to assess three dimension of exercise related self efficacy (task, scheduling and coping).
Baseline and end of 10 weeks of active participation
Change in social support
Time Frame: Baseline and end of 10 weeks of active participation
We will use the Social support and exercise survey (SSES) to assess social support. SSES is 26 item survey of social support for exercise available to the individual using separate (13 item) scales each for friends and for family.
Baseline and end of 10 weeks of active participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kelly McDermott, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-10688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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